Quality Assurance

Our Quality services based on vast knowledge and experience. We provide guidance and support pharma and medical device companies with implementing local and international quality guidelines.

Providing Qualified Person Batch Certification for chemical and biological products.
Establishing and maintaining quality systems to meet local regulations, including:

  • Training teams
  • SOP development and maintenance
  • Management of  quality complaints and deviations
  • Corrective and Preventive Action (CAPA) planning and execution
  • Coordination and Execution of quality and supplier audits
  • Implementation and Management of Quality Agreements/Technical Agreements with suppliers
  • Preparing for agency or internal corporate inspections
  • Supply chain management
  • GMP/GDP Compliance programs
  • Preparations of importers for license importation